UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013169 |
|---|---|
| Receipt number | R000015356 |
| Scientific Title | Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma (Once weekly VRd-21, I/II VRD for MM) |
| Date of disclosure of the study information | 2014/02/15 |
| Last modified on | 2016/02/22 10:57:55 |
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Basic information
Public title
Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)
Acronym
Phase I/II study of once weekly VRd-21 for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)
Scientific Title
Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)
Scientific Title:Acronym
Phase I/II study of once weekly VRd-21 for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)
Region
| Japan |
Condition
Condition
Proteasome inhibitor and immunomodulatory drug pre-treated relapsed and/or refractory multiple myeloma after two or more prior lines of chemotherapy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to evaluate the safety and efficacy of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed or refractory multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
maximum tolerated dose
objective response rate, PR above
Key secondary outcomes
overall survival
progression-free survival
time to progression
adverse event
treatment efficacy according to the translocation of chromosome myeloma related
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
bortezomib (subcutaneous injection, days 1,8) plus lenalidomode (days 1-14) dexamethasone (20mg/day, days
1,2,8,9) were administered for eight 21-cycles.
Phase1
level -1
bortzomib 1.0 mg/m2, lenalidomide 10 mg/body, dexamethasone 20 mg/body
level 1
bortzomib 1.3 mg/m2, lenalidomide 10 mg/body, dexamethasone 20 mg/body
level 2
bortzomib 1.3 mg/m2, lenalidomide 15mg/body, dexamethasone 20 mg/body
Phase2
At the Phase 2 study, adminstration was decided based on the result of Phase 1 study
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) diagnosed as having symptomatic multiple myeloma before initial treatment
2) relapsed and or refractory cases after at least two prior chemotherapy including both proteasome inhibitor and one immunomodulatory drug
3) no limit of age
4) either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy. Females of childbearing potential must adhere to the guideline of the Revmate program.
5) men who agreed to use contraception according to the guideline of the Revmate program.
6) performance status 0-2,or 3 due to osteolytic lesions alone
7) having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0gdL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA IgD, or urinary excretion of at least 0.2g of paraprotein per 24 hours in spite of the type of myeloma
8) at least 14 days have passed after the prior therapy of multiple myloma, including chemotherapy, radiotherapy, and surgery. Transient administration of steroid is permitted
9) absolute neutrophil count no less than 750/mm3, platelet count no less than 50,000/mm3,
, AST/ALT no more than 100IU/L, total bilirubin 1.8 mg/dL or below, creatinine clearrance 50 mL/min or above at phase 1 study (no limitation at the phase 2 study except for need of dialysis),
SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia reqiuring medical intervention, cardiac ejection fraction at least 50%
10) no history of hypersensitivity to bortezomib, lenalidomide, and dexamethasone
11) peripheral neuropathy(PN) within grade 2 without pain. Management of PN is permitted.
12) written informed consent by the patient
Key exclusion criteria
1) synchronous or metachronous malignancy
2) active infection
3) severe constipation or illeus
4) interstitial pneoumonia, pulmonary fibrosis
5) uncontrolled diabetes
6) inability to intake antithrombotic medication
7) pregnant or nursing women mellitus
8) uncontrollable hypertension
9) psychological disturbance
10) active double cancer
11) HBs-Ag positive or HCV-Ab positive or HIV-Ab positive
12) grade 3 or higher peripheral neuropathy, or grade 1 or higher neuralgia
13) glaucoma
14) primary plasma cell leukemia
15) no adminstration of blood transfusion or G-CSF within 7days befor the treatment
16) no evidence of cardiac or intestinal amyloidosis
17) allergic history to borate or mannitol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Ri |
Organization
Nagoya City University Hospital
Division name
Division of Hematology & Collagen Diseases
Zip code
Address
1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL
052-853-8217
rrmasaki@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhito Totani |
Organization
Nagoya City University Hospital
Division name
Division of Hematology & Collagen Diseases
Zip code
Address
1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL
052-853-8217
Homepage URL
shimuroini0421@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋市立大学病院
名古屋記念病院
豊川市民病院
厚生連 海南病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 15 | Day |
Last modified on
| 2016 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015356
